Medications come in a variety of shapes, sizes, dosages, and forms with specific intentions for each variation and unique quality presented. This section is to help understand the process of medication discovery and production in an effort to best understand the overall component of prescription medication entrance into the marketshare and why things occur in the manners that they commonly have in the past.
For this section, most of these topics are high-level components to simply know these aspects exist. This helps pharmacy personnel understand the process in an effort to best explain to patients the reasons for expense, lack of therapy (or new therapy where current exists), or why a studied medication in a trial still is not approved for general use. The categories below help shape the general flow most medications find themselves within from discovery to consumer.
Drug Discovery
Identifying disease targets needing a new therapy
Screening compounds that could potentially aid in one or more fashion of the disease targets
Preclinical Testing
Lab and animal studies for safety
Clinical Trials (Phases I–IV)
Phase I: Safety (small group) – just ensuring preclinical testing results are valid for humans.
Phase II: Effectiveness + side effects – ensuring proper dose is truly responding well
Phase III: Large-scale testing
Phase IV: Post-market monitoring
FDA Drug Application Process
IND (Investigational New Drug)
NDA (New Drug Application)
ANDA (for generics)
Market Entry
Approval → Manufacturing → Distribution → Pharmacy dispensing
Understanding why some drugs are expensive
Recognizing new vs. established medications
Awareness of recalls and safety alerts